Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
FDA Recall Z-1628-2018 · Posted None
Recalling FirmTeleflex Medical Europe Ltd
Recall StatusTerminated
Product CodeCCT
Date Initiated2018-03-19
Date Terminated2019-08-27
Product Quantity25 units
Reason for Recall
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Firm Action
The recall notice was disseminated by letter on 03/19/2018. The letter stated the following:
"1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number listed above.
2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter."
Root Cause
Process control
Distribution Pattern
TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.